Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05738395 |
Other study ID # |
3494 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 1, 2020 |
Est. completion date |
November 1, 2025 |
Study information
Verified date |
February 2023 |
Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to describe the prevalence of typical and atypical
signs and symptoms of Frey's syndrome, the affected areas and the severity of each
symptom/sign.
Participants will be asked will asked about
- Presence or the absence of: a. gustatory sweating; b. gustatory flushing; c. gustatory
itching; d. paresthesia; e. pain
- Grade of severity: a. absence; b. mild; c. moderate; d. almost severe; e. severe
- Affected area: a. preauricular; b. retroauricolar; c. temporal; d. retrangulomandibular;
e. cheek
Description:
The Frey's syndrome classically appears with sweating and hyperemia that occur almost
immediately after tasting foods, particularly spicy ones, in the distribution of the
auriculotemporal nerve region hence it is also called "auriculotemporal syndrome". The
synkinetic mechanism for Frey's syndrome supposes an aberrant regeneration of the
parasympathetic fibers because they normally innervate the parotid gland and, after losing
their parotid targets, they regenerate to innervate the facial skin vessels and sweat glands.
As a consequence, this results in a local vasodilatation (gustatory flushing) and localized
sweating (gustatory sweating) of the sympathetically void skin in response to mastication and
salivation (Drummond PD, 2002; Rustemeyer J et al., 2008; Neumann A e al., 2011; Gardner WJ
et al., 1956). The etiology may be traumatic (parotidectomy, abscess drainage, bullet wound)
(Rouyer J., 1959; Botkin S., 1875) or nontraumatic (autonomic neuropathy in diabetes
mellitus, herpes zoster infection, metabolic diseases, etc.) (New GB, 1922). The most
frequent etiologic factor is undoubtedly the parotidectomy. Parotid gland tumors are among
the most common neoplasms in the head and neck region, and a variable portion (Linder TE et
al., 1997; Bussu F et al., 2011; May JS, 1989). Ranging from 17% up to 100% of patients who
underwent parotidectomy are affected by Frey's syndrome, depending whether or not they
performed specific test. Grossly half of them notice symptoms and feel the gustatory
sweating. Around 13-23% of patients consider their symptoms troublesome and severe (Laskawi
RT et al., 1996; May JS, 1989). Potential negative social and psychologic implications of
this condition can be significant, and treatment ranging from topical agents (glycopyrrolate)
to local injections of botulinum toxin (Botox) to surgical intervention (i.e. temporoparietal
fascia flap interposition) should be offered to patients (Hays LL, 1982). Moreover the Frey's
syndrome, in addition to the gustatory sweating and flushing almost constant with a variable
severity, can be associated with other atypical symptoms. The sensation of heat, itch and
pain in the distribution of the auriculotemporal nerve were not mentioned as accompanying
symptoms in the original description of the syndrome by Frey (Frey L., 1923). The pain is an
uncommon finding, reported in less than 10% of cases (Bednarek J et al., 1976). It can be an
early symptom and may remain the only one. Usually described as constant aching or burning,
De Benedettis et al. (1990) reported two cases in which pain was the predominant symptom.
Gustatory itch was described anecdotally by Ricks et al. (2010) as a sequela of superficial
parotidectomy; a neurophysiological pathway involving acetylcoline and histamine has been
proposed to explain this phenomenon. It cannot be ruled out that the presence of pain and
itch is under-reported in the literature because they are generally not predominant, and the
patient is often not specifically asked about. A systematic comprehensive assessment of Frey
related complaints is currently missing. Most studies describe a single manifestation or the
predominant ones basing simply on the absence or presence of symptoms and signs (Jansen S et
al., 2017) without a graduation of them.
Study design and setting This will be a no-profit observational cross-sectional pilot study.
Patients addressed to the Otolaryngology Unit of our Institution with a diagnosis of Frey
syndrome will be consecutively enrolled, if matching inclusion criteria. The expected
duration of the study will be two years.
Objectives
Primary
- To describe the prevalence of typical and atypical signs and symptoms of Frey's
syndrome, the affected areas and the severity of each symptom/sign Secondary
- To describe the global severity of the Frey's syndrome in the group of the study;
- To describe the severity of Frey's syndrome in relation to the history data (etiology,
age, sex, comorbidities, surgical procedure, age of onset)